Bioequivalence and Bioavailability Forum • Comp in-vitro disso studies for generics in India

Comp in-vitro disso studies for generics in India [Dissolution / BCS / IVIVC]

posted by jag009 – NJ, 2020-03-15 07:25 – Posting: # 21271
Views: 1,225

Hi,

» I know the US rules but not if it's the same as in India...
»
» Please let us know the US rules.

In terms of disso, for US you have to follow the FDA recommended dissolution method listed for the designated reference product. If there is no FDA method then you use the USP method.

Thx
J

Complete thread:

Comp in-vitro disso studies for generics in India jag009 2020-03-12 15:41 [Dissolution / BCS / IVIVC]
- Comp in-vitro disso studies for generics in India ping4santosh 2020-03-12 19:18
  - Comp in-vitro disso studies for generics in India jag009 2020-03-13 17:34
    - Comp in-vitro disso studies for generics in India ping4santosh 2020-03-14 23:20
      - Comp in-vitro disso studies for generics in Indiajag009 2020-03-15 07:25
        
        Comp in-vitro disso studies for generics in India ping4santosh 2020-03-15 10:05